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Authorize Generic GLP-1s: Public Citizen

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Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nord...

Court Says Warning Letter Can be Final FDA Action

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Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybr...

Researchers Urge FDA Caution in Phasing Out Animal Testing

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A new academic paper urges FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that mov...

FDA Faces High Hurdle to Expand DTC Ad Disclosures: WLF

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A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramati...

FDA OKs Pulling Boxed Warnings from 6 HRT Drugs

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FDA approves labeling changes removing some Boxed Warnings from six hormone replacement therapy products.

Legal Scholars Warn Infringement by Label Will Harm Generics

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A new article in the New England Journal of Medicine warns that recent federal court rulings are transforming FDA-required drug la...

Turmoil Mounts Under Prasads Leadership: WSJ

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CBER faces mounting scrutiny after its top official, director Vinay Prasad, refused the review of Modernas flu vaccine application...

11 Observations in Eugia Pharma Inspection

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FDA releases the form FDA-483 with 11 observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturin...

Inhaled Gene Therapy for Lung Cancer Gets Expedited Status

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FDA awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investi...

Keytruda Regimen for PD-L1Positive Ovarian Cancers Approved

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FDA approves Mercks Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph ...